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Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460862
Recruitment Status : Unknown
Verified November 2017 by Novartis ( Novartis Pharmaceuticals ).
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
A retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose Inhaled Corticosteroids (ICS) prior to initiating omalizumab.

Condition or disease
Asthma

Study Design
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Study Type : Observational
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analyze the Impact of Omalizumab on Corticosteroid Use, Emergency Room Visits and Hospitalizations Among Patients With Uncontrolled Asthma Receiving High Dose Inhaled Corticosteroids
Study Start Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Omalizumab

Groups and Cohorts
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Group/Cohort
Omalizumab Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of emergency-department visits and hospitalizations [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with uncontrolled asthma and using high-dose ICS prior to initiating omalizumab.
Criteria

Inclusion Criteria:

  • ≥12 years of age with a documented Cystic fibrosis (CF) diagnosis,
  • on Long acting Beta antagonist- Inhaled Corticosteroid (LABA-ICS) at baseline,
  • uncontrolled asthma at baseline.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460862


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01460862    
Other Study ID Numbers: HEORUS0091
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma
Omalizumab
Additional relevant MeSH terms:
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Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes